Coronary Angiography (CAG)NCT07032935
The Effect of Virtual Reality Glasses on Vital Signs and State Anxiety in Patients Undergoing Coronary Angiography
A study testing Virtual Reality (VR) Intervention in people with Coronary Angiography (CAG), run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
Trial summary
Virtual reality (VR) is an effective, safe, and non-pharmacological intervention for reducing anxiety, with strong scientific evidence and no known adverse effects. By providing relaxation and distraction, VR suppresses sympathetic nervous system activity while enhancing parasympathetic activity, thereby promoting a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Angiography (CAG)
- What is being tested?
- Virtual Reality (VR) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 May 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients who receive sedation, patients who cannot communicate, patients with visual or hearing impairments, and individuals who do not agree to participate in the research will be included.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mehmet A Astarcıoğlu, Professor contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Kutahya Health Sciences University
Kütahya
BURCU NAL, PhD, 05077769735, burcu.nal@ksbu.edu.tr
- Recruiting
Kütahya Health Sciences University
Merkez, Kütahya, 43000
BURCU NAL, PhD, 05077769735, burcu.nal@ksbu.edu.tr
About this study
Official title: AI-Supported Analysis of the Effectiveness of Virtual Reality Application in Coronary Angiography Patients: A Randomized Controlled Study on Vital Signs and State Anxiety
Virtual reality (VR) is an effective, safe, and non-pharmacological intervention for reducing anxiety, with strong scientific evidence and no known adverse effects. By providing relaxation and distraction, VR suppresses sympathetic nervous system activity while enhancing parasympathetic activity, thereby promoting a relaxation response.
VR immerses patients in a virtual environment, diverting attention from stressful clinical settings and reducing anxiety, fear, and worry. This psychological effect is accompanied by favorable physiological responses, including reductions in blood pressure (BP), heart rate (HR), and respiratory rate (RR), as well as improvements in peripheral oxygen saturation (SpO₂).
Read more
Previous studies have demonstrated the effectiveness of VR in reducing preoperative anxiety across various clinical settings. For example, VR has been shown to decrease anxiety in adult patients undergoing sternotomy, reduce anxiety before maxillofacial surgery, and provide anxiety relief comparable to progressive muscle relaxation during arthroscopic knee surgery. These findings support the use of VR as an accessible and cost-effective intervention for anxiety management.
In recent years, artificial intelligence (AI) has emerged as a valuable tool for analyzing complex clinical data and identifying patterns that may not be detected using conventional statistical methods. AI-supported analyses can integrate physiological measurements with patient-reported outcomes to provide a more comprehensive evaluation of intervention effectiveness.
Despite growing evidence supporting VR interventions, no previous study has evaluated the effectiveness of VR in patients undergoing coronary angiography using both conventional outcome measures and AI-supported analytical approaches. Therefore, this randomized controlled study aims to investigate the effects of a VR intervention on state anxiety and vital signs in patients undergoing coronary angiography while applying AI-supported analyses to improve the evaluation of intervention effectiveness.
Read the detailed description
This randomized controlled study will investigate the effect of a virtual reality (VR) intervention on state anxiety and vital signs in patients undergoing coronary angiography.
Eligible patients scheduled for coronary angiography will be randomly assigned to either a VR intervention group or a control group. During the coronary angiography procedure, participants in the VR intervention group will use VR glasses for 15 minutes. The VR content will consist of relaxing audiovisual environments, including underwater museum, nature, and similar calming scenes. The intervention is designed to provide visual and auditory distraction and promote relaxation during the procedure.
Participants in the control group will receive routine care during coronary angiography without the VR intervention.
State anxiety will be assessed using the State Anxiety Scale at predefined assessment points. Vital signs, including blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation (SpO₂), will be measured and recorded before, during, and after coronary angiography.
The primary outcome of the study is the change in state anxiety associated with the VR intervention. Secondary outcomes include changes in vital signs, including blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation.
In addition to conventional statistical analyses, artificial intelligence-supported analyses will be performed using the collected clinical and physiological data to identify patterns and further evaluate the effects of the VR intervention. The study aims to determine whether a 15-minute VR intervention during coronary angiography can reduce state anxiety and positively influence physiological responses compared with routine care.
- Conditions
- Coronary Angiography (CAG)
- Being tested
- Virtual Reality (VR) Intervention
- Keywords
- coronary angiography, virtual reality glasses, vital signs, Artificial Intelligence, Patient Anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) InterventionBehavioural
Also called Virtual Reality Glasses
A 15-minute virtual reality intervention will be administered during coronary angiography. Participants will use VR glasses to watch relaxing audiovisual content, including underwater museum and nature videos, as a non-pharmacological distraction and relaxation intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants in this group will receive routine care during coronary angiography without the use of virtual reality. |
| virtual reality glasses Group | Experimental | Participants in this group will use virtual reality glasses for 15 minutes during coronary angiography. They will watch relaxing audiovisual content, including underwater museum and nature videos, as a non-pharmacological distraction and relaxation intervention Receives: Behavioral: Virtual Reality (VR) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Score
Before and after the intervention (pre- and post-intervention) It will be measured using the State Anxiety Inventory (STAI-I). The score varies between 20 and 80.
Measured: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
Secondary outcomes (4)
Change in Vital Signs (Heart Rate)
To be measured before and after the virtual reality intervention
Measured: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
Change in Vital Signs (Blood Pressure)
To be measured before and after the virtual reality intervention
Measured: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
Change in Vital Signs (Respiratory Rate)
To be measured before and after the virtual reality intervention
Measured: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
AI-Supported Analysis of Intervention Effectiveness
Artificial intelligence-based analytical models will be used to evaluate the relationship between virtual reality application, state anxiety, and physiological parameters (SBP, DBP, HR, RR, and SpO₂), and to identify the variables that best predict intervention effectiveness.
Measured: Immediately after completion of the intervention and study data analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start30 May 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Angiography (CAG)Studies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Artificial intelligence-based models will be developed using demographic characteristics, clinical variables, state anxiety scores, and physiological parameters (heart rate, blood pressure, respiratory rate, and peripheral oxygen saturation) collected before and after the virtual reality intervention. Machine learning algorithms will be trained and internally validated to identify patterns associated with the effectiveness of the intervention. Model performance will be evaluated using standard metrics, including accuracy, sensitivity, specificity, precision, F1-score, and the area under the receiver operating characteristic curve (AUC).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BURCU NAL, Principal investigator, Kütahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032935
- Sponsor's protocol ID
- KutahyaHSU20260405
- Status last verified
- May 2026
- First submitted
- 11 Jun 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Supported Analysis of the Effectiveness of Virtual Reality Application in Coronary Angiography Patients: A Randomized Controlled Study on Vital Signs and State Anxiety
- ClinicalTrials.gov ID
- NCT07032935
- Acronym / sponsor ID
- KutahyaHSU20260405
- Conditions
- Coronary Angiography (CAG)
- Keywords
- coronary angiography, virtual reality glasses, vital signs, Artificial Intelligence, Patient Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 May 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Virtual reality (VR) is an effective, safe, and non-pharmacological intervention for reducing anxiety, with strong scientific evidence and no known adverse effects. By providing relaxation and distraction, VR suppresses sympathetic nervous system activity while enhancing parasympathetic activity, thereby promoting a relaxation response.
VR immerses patients in a virtual environment, diverting attention from stressful clinical settings and reducing anxiety, fear, and worry. This psychological effect is accompanied by favorable physiological responses, including reductions in blood pressure (BP), heart rate (HR), and respiratory rate (RR), as well as improvements in peripheral oxygen saturation (SpO₂).
Previous studies have demonstrated the effectiveness of VR in reducing preoperative anxiety across various clinical settings. For example, VR has been shown to decrease anxiety in adult patients undergoing sternotomy, reduce anxiety before maxillofacial surgery, and provide anxiety relief comparable to progressive muscle relaxation during arthroscopic knee surgery. These findings support the use of VR as an accessible and cost-effective intervention for anxiety management.
In recent years, artificial intelligence (AI) has emerged as a valuable tool for analyzing complex clinical data and identifying patterns that may not be detected using conventional statistical methods. AI-supported analyses can integrate physiological measurements with patient-reported outcomes to provide a more comprehensive evaluation of intervention effectiveness.
Despite growing evidence supporting VR interventions, no previous study has evaluated the effectiveness of VR in patients undergoing coronary angiography using both conventional outcome measures and AI-supported analytical approaches. Therefore, this randomized controlled study aims to investigate the effects of a VR intervention on state anxiety and vital signs in patients undergoing coronary angiography while applying AI-supported analyses to improve the evaluation of intervention effectiveness.
Detailed description
This randomized controlled study will investigate the effect of a virtual reality (VR) intervention on state anxiety and vital signs in patients undergoing coronary angiography.
Eligible patients scheduled for coronary angiography will be randomly assigned to either a VR intervention group or a control group. During the coronary angiography procedure, participants in the VR intervention group will use VR glasses for 15 minutes. The VR content will consist of relaxing audiovisual environments, including underwater museum, nature, and similar calming scenes. The intervention is designed to provide visual and auditory distraction and promote relaxation during the procedure.
Participants in the control group will receive routine care during coronary angiography without the VR intervention.
State anxiety will be assessed using the State Anxiety Scale at predefined assessment points. Vital signs, including blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation (SpO₂), will be measured and recorded before, during, and after coronary angiography.
The primary outcome of the study is the change in state anxiety associated with the VR intervention. Secondary outcomes include changes in vital signs, including blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation.
In addition to conventional statistical analyses, artificial intelligence-supported analyses will be performed using the collected clinical and physiological data to identify patterns and further evaluate the effects of the VR intervention. The study aims to determine whether a 15-minute VR intervention during coronary angiography can reduce state anxiety and positively influence physiological responses compared with routine care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Artificial intelligence-based models will be developed using demographic characteristics, clinical variables, state anxiety scores, and physiological parameters (heart rate, blood pressure, respiratory rate, and peripheral oxygen saturation) collected before and after the virtual reality intervention. Machine learning algorithms will be trained and internally validated to identify patterns associated with the effectiveness of the intervention. Model performance will be evaluated using standard metrics, including accuracy, sensitivity, specificity, precision, F1-score, and the area under the receiver operating characteristic curve (AUC).
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants in this group will receive routine care during coronary angiography without the use of virtual reality. |
| virtual reality glasses Group | Experimental | Behavioral: Virtual Reality (VR) InterventionParticipants in this group will use virtual reality glasses for 15 minutes during coronary angiography. They will watch relaxing audiovisual content, including underwater museum and nature videos, as a non-pharmacological distraction and relaxation intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients who receive sedation, patients who cannot communicate, patients with visual or hearing impairments, and individuals who do not agree to participate in the research will be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR) InterventionAlso: Virtual Reality GlassesA 15-minute virtual reality intervention will be administered during coronary angiography. Participants will use VR glasses to watch relaxing audiovisual content, including underwater museum and nature videos, as a non-pharmacological distraction and relaxation intervention. | Behavioural | virtual reality glasses Group |
Primary outcome
Change in State Anxiety Score
Time frame: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
Before and after the intervention (pre- and post-intervention) It will be measured using the State Anxiety Inventory (STAI-I). The score varies between 20 and 80.
4 secondary outcomes
Change in Vital Signs (Heart Rate)
Time frame: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
Change in Vital Signs (Blood Pressure)
Time frame: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
Change in Vital Signs (Respiratory Rate)
Time frame: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed
AI-Supported Analysis of Intervention Effectiveness
Time frame: Immediately after completion of the intervention and study data analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehmet A Astarcıoğlu, Professor contact
BURCU NAL principal investigator
Kütahya Health Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) Intervention in people with Coronary Angiography (CAG), run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burcu Nal, PhD (+905077769735, burcu.nal@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Score (time frame: Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.